MAUDE Adverse Event Report: ST. JUDE MEDICAL PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 1688TC

Device Problems Signal Artifact/Noise (1036); High Capture Threshold (3266)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This rv lead was implanted on (b)(6) 2007 remains implanted at this time.A call was placed to technical services on 05/01/2018 stating that this lead exhibited noise.Clinic has been following patient since 2011 and has had low level of noise since then.Stored events show noise on both leads with no over-sensing noted.Noise appears to happen in morning when patient is getting ready for work with time stamps from 5 am to 8 am.Threshold has been increasing over the last year with a test threshold today of 1.9 volts in the rv.Isometrics show noise on rv lead when stretching toward ceiling and over to the back in the rv channel but not on the ra.Clinic will bring patient back in three months to clinic.The physician was dr.(b)(6) at (b)(6) in (b)(6), iowa.No other information available.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17530601
• MDR Text Key: 321337220
• Report Number: MW5137519
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1688TC
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1